Disc and vertebral defect packing tape

ABSTRACT

Embodiments of the invention include a disc or vertebral defect packing tape for use in disc fusion, disc regeneration or for the creation of artificial disks. The tape comprises a tape body and one or more support members. Each of the support members is contained within the tape body and/or adhered to an external surface of the tape or tape body. The tape body is configured as a packing material and each of the support members is configured to hold the tape body together.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation-in-part of and claims priority toU.S. Ser. No. 15/384,301 filed on Dec. 19, 2016, entitled “Disc andVertebral Defect Packing Tape,” the contents of which are incorporatedherein by reference in its entirety.

FIELD OF INVENTION

The present disclosure relates generally to field of surgery and inparticular to novel materials and methods for correction of spinaldefects during orthopaedic surgeries.

BACKGROUND

The background description includes information that may be useful inunderstanding the present invention. It is not an admission that any ofthe information provided herein is prior art or relevant to thepresently claimed invention, or that any publication specifically orimplicitly referenced is prior art.

Orthopaedic spinal defects can be either congenial or can develop laterin life because of trauma or ageing causing damage/degeneration ofspinal bones. They may also develop on account of bad posture.Conservative care can generally be the first option for treatment ofsuch spinal defects. However, it may always not give the best resultsand intervention through corrective surgery may have to be resorted to.

Spinal surgeries typically require packing of intervertebral space forstabilizing a disc with the intention of fusing vertebras, creating anartificial disc or regeneration of the disc using stem cells or suchsimilar materials. This may be preceded by removal of herniated/bulgingdisc material that may be pressing a nerve root/spinal cord or totalremoval of the disc. The disk will have an empty space, after partial ornear total discectomy. The empty space may also result from trauma ordegeneration. Similar empty space may result in the vertebral body/bonefrom trauma, degeneration, or surgery and all such cases require packingof empty space.

Many biocompatible and bio-absorbable materials such as collagen fibers,silk fibers, collagen gels, cements, Plaster of Paris, etc. have beendeveloped to meet such surgical requirements. But just matching themechanical properties especially in musculoskeletal system is notsufficient for efficient load transfer. The host tissues mustsuccessfully integrate with these materials and vascularize. Furtherthese materials are suitable either for packing intervertebral space orempty space in vertebral body/bone. It is required to have a packingmaterial that can be used both for process of bone implantation and alsofor inter vertebral disc and mimic the physiological and thebiomechanical function of the replaced disc.

SUMMARY

There is a need for a device for use during spinal surgeries for packingempty intervertebral space and empty space in vertebral body/bone. Thepacking of intervertebral space or empty space in vertebral body/bonemay be to stabilize a disc with the intention of fusing vertebras,creating an artificial disc or regeneration of the disc or toreconstruct missing portion of the bone from trauma, degeneration, orsurgical excisions.

A novel packing device referred to as disc or vertebral defect packingtape (“tape”) is provided that meets the above described requirementsand overcomes limitations of existing packing devices. As used herein,the term “tape” means, without limitation, a disc or a bonepacking/fusion/regeneration device.

According to an embodiment, the tape comprises: (1) a tape body and; (2)one or more support members. The support member can be an endoskeletonor an exosekelton. The support members can be contained within the tapebody, envelope an external surface of the tape body or they can becontained within the tape body and also envelope an external of the tapebody. The tape body functions as a disc packing material and the supportmember holds the tape body together.

The support member can be made of a soft biocompatible material such aspolyethylene, nylon, silk, titanium or any other similar material.Alternatively it can be made of any suitable biologically absorbablematerial.

According to another embodiment, the support member comprises aplurality of metallic beads. The beads may be sized such that they areenclosed within the tape body. The beads can made of titanium or anothersuitable material. Each of the beads can be spaced apart from anadjacent bead by a predetermined distance. Alternately, the beads can beconnected with extremely thin titanium fiber. For instance, the fibermay have the diameter of a strand of human hair. The support member cancomprise one or more than one rows of these beads. In anotherembodiment, the support member can be configured as a single strand oras a braided wire.

The tape body comprises a biologically absorbable material. Forinstance, the tape body includes morselized bone, finely groundmaterials or a combination thereof. For example, the tape body cancomprise or be impregnated with a biocompatible material, morselizedallograft, finel ground materials, polyethylene, bone marrow or BMP (orany osteo-inductive or osteo-genic material), biological glue/biologicalcement, stem cells or other such material, and combinations thereof, andcan be used for disc or bone fusing and regeneration without any otherfilling material. In yet another embodiment, the tape body can be ofcable-type having a circular cross-section.

According to an embodiment, an impacting instrument can be configuredfor packing the tape tightly into the spacing between discs or within abone defect.

In one embodiment, the tape can be used in combination with polyethyleneballs for creating an artificial disc.

In one embodiment, a method of fusing a disc involves packing of emptyintervertebral space and empty space in vertebral body with the tape.Each disc includes a strong outer ring of fibers called the annulusfibrosus and a soft, jelly-like center called the nucleus. After thetape is packed, a defect in the annulus may be covered/closed using a“annulus cover”. The annulus cover that can comprise a square orrectangular sheet. The sheet can comprise a soft material used in thebody of the tape. In an aspect, the method further involves stapling the“annular cover” in place.

Various objects, features, aspects and advantages of the inventivesubject matter will become more apparent from the following detaileddescription of preferred embodiments, along with the accompanyingdrawing figures in which like numerals represent like components.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-FIG. 1L″ illustrate exemplary views of a tape in accordancewith one or more embodiments

FIGS. 2A-FIG. 2C illustrate exemplary schematic representations of anempty disc space packed with a tape for disc fusion or regeneration inaccordance with one or more embodiments.

FIGS. 3A-FIG. 3B illustrate exemplary schematic representations of anempty disc space packed with a tape in accordance with one or moreembodiments.

FIG. 4 illustrates an exemplary schematic representation of an emptydisc space packed with a tape in accordance with one or moreembodiments.

FIG. 5 illustrates an exemplary process flow diagram for disc fusionusing the tape in accordance with an embodiment.

FIG. 6 illustrates an exemplary process flow diagram for creating anartificial disc using the tape in accordance with an embodiment.

FIG. 7 illustrates an exemplary process flow diagram for discregeneration using the tape in accordance with an embodiment.

FIGS. 8A and 8B illustrate an exemplary instrument for creating lordosisin accordance with an embodiment.

DETAILED DESCRIPTION

The following is a detailed description of embodiments of the disclosuredepicted in the accompanying drawings. The embodiments are in suchdetail as to clearly communicate the disclosure. However, the amount ofdetail offered is not intended to limit the anticipated variations ofembodiments; on the contrary, the intention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the present disclosure as defined by the appended claims.

Each of the appended claims defines a separate invention, which forinfringement purposes is recognized as including equivalents to thevarious elements or limitations specified in the claims. Depending onthe context, all references below to the “invention” may in some casesrefer to certain specific embodiments only. In other cases it will berecognized that references to the “invention” will refer to subjectmatter recited in one or more, but not necessarily all, of the claims.

As used in the description herein and throughout the claims that follow,the meaning of “a,” “an,” and “the” includes plural reference unless thecontext clearly dictates otherwise. Also, as used in the descriptionherein, the meaning of “in” includes “in” and “on” unless the contextclearly dictates otherwise.

All methods described herein can be performed in any suitable orderunless otherwise indicated herein or otherwise clearly contradicted bycontext. The use of any and all examples, or exemplary language (e.g.“such as”) provided with respect to certain embodiments herein isintended merely to better illuminate the invention and does not pose alimitation on the scope of the invention otherwise claimed. No languagein the specification should be construed as indicating any non-claimedelement essential to the practice of the invention.

Various terms are used herein. To the extent a term used in a claim isnot defined below, it should be given the broadest definition persons inthe pertinent art have given that term as reflected in printedpublications and issued patents at the time of filing.

Referring now to FIG. 1A to FIG. 1L″, exemplary views of a disc andvertebral defect packing tape (“tape”) are disclosed. The tape comprisesa tape body and one or more support members. The tape body can be madeup of biocompatible material, finely ground materials, allograft,polyethylene, etc., or a bio absorbable material and combinationsthereof. The support member can be made of titanium. The support membercan also be made of a soft biocompatible material such as polyethylene,nylon, silk or any other similarly suitable material, including, bioabsorbable material. The tape body, depending on intended purpose, canbe further impregnated with one or combination of other materials suchas bone marrow or BMP (or any osteo-inductive or osteo-genic material),biological glue/biological cement, stem cell etc. Alternatively the tapebody can be devoid any such impregnation. The tape body can beconfigured to have a plurality of different widths and thickness.Additionally, the tape body may have a greater width and thickness thanthe support members.

The tape body functions as a disc packing material and the supportmember holds the tape body together. In one more embodiments, thesupport member may have a relatively small diameter and its thicknessmay be comparable to a strand of human hair.

Referring now to FIG. 1A, the tape 100 comprises a tape body 102 and asupport member 104. The tape body 102 can be a flattened strip. Thesupport member 104 may be contained within the tape body 102.

FIG. 1B depicts another embodiment of the tape 110. As shown, the tape110 comprises a tape body 112 and a support member 114. The supportmember 114 includes comprising a plurality of beaded elements 116. Asshown in FIGS. 1B and 1B′, the beaded elements 106 may be interconnectedusing a suitable connector 118. The beaded elements 116 may be arrangedin a row. Each of the beaded elements may be spaced apart from anadjacent beaded element by a predetermined distance. The connector 118can be a fiber made of titanium or a fiber made of another suitablematerial. Alternately, the connector 118 can be a suitable medical orbiocompatible adhesive.

Another embodiment is illustrated in FIG. 1C. As shown, the tape 120 caninclude a tape body 122. Two support members 124A and 124B (collectively“support members 124”) may be contained within the tape body 122. Thesupport members 124 comprises a plurality of beaded elements 126. Asdescribed with reference to FIG. 1B, the beaded elements 126 may beinterconnected by a connector 128.

FIG. 1D depicts yet another embodiment of tape 130. As shown, the tape130 comprises a tape body 132. The tape body 132 may have a cylindricalor cable-type structure. A single stranded wire-like support member 134may be enclosed within the tape body 132. The support member 134 is madeof a suitable material. For example, the support member 134 comprises asingle strand of titanium wire.

FIG. 1E depicts another embodiment of tape 140. As shown, the tape 140comprises a tape body 142. The tape body 142 may have a cylindrical orcable-type structure. A braided wire-like support member 144 may beenclosed within the tape body 142. The support member 144 is made of asuitable material. For example, the support member 144 comprises abraided titanium wire.

FIG. 1F depicts another embodiment of the tape 150. As shown, the tape150 includes a rectangular-shaped tape body 152. A single strandedwire-like support member 154 is contained within the tape body 152.

FIG. 1G depicts yet another embodiment of the tape 160. As shown, thetape 160 includes a rectangular-shaped tape body 162. A braidedwire-like support member 164 is enclosed within the tape body 162.

FIG. 1H depicts yet another embodiment of tape 170. As shown, the tape170 includes a rectangular-shaped tape body 172. A support member 174comprising a plurality of beads 176 may be contained within the tapebody 172. The beads 176 may be interconnected with a suitable connector178 described earlier.

FIGS. 1K and 1K′ depict perspective and vertical-sectional views ofanother embodiment of the tape 180. As shown, the tape 180 is devoid ofa tape body such that the tape 180 only includes a support member 182.As shown, the support member 182 is an exoskeleton (as opposed to theendoskeleton depicted in FIGS. 1-H).

FIGS. 1L, 1L′ and 1L″ depict perspective, vertical-sectional andcross-sectional views of another embodiment of the tape 190. The tape190 includes a tape body 192. The tape 190 further includes an internalsupport member 194A. As shown, the internal support member 194Acomprises a plurality of beaded elements 196. The beaded elements 196may be connected with a connector 198. The tape 190 further includes anexoskeleton or external support member 194B that substantially covers orenvelops the internal support member 194A and the tape body 192.

It would be obvious to a person skilled in the art that the number,nature and position of the support members can be varied withoutdeviating from the scope of the invention. For example, it may bepossible to have one or more support members embedded within the tapebody and one or more support members located on an external surface ofthe tape body. The support members may be interconnected or individualbeaded elements, straight wires, braided wires, strands, etc. It isunderstood that each of these embodiments is encompassed within thescope of the present invention.

FIGS. 2A-2C illustrate using an embodiment of the tape, described above,for facilitating disc fusion or disc regeneration. FIG. 2A illustrates aperspective view 200A of a tape 202 packed in an empty disc space 210.The tape 202 can include a tape body 204 and a support member 206. Theempty space 210 is present between two parts 212 and 214. In practice,parts 212 and 214 can be vertebrae of the spine and empty space 210 canbe a void left after discectomy that may need filling for the purpose ofdisc fusing or disc regeneration. Alternatively, the empty space 210 canbe within a vertebra body that may need packing to reconstruct missingportions of the bone due to trauma, degeneration, or surgical excision.In practice, the anterior portion of the empty space 210 may be firstpacked with a first substance 208. The first substance 208 may includemorselized or finely ground bone, bone graft, biocompatible materiallike allograft or other osteo-genic, osteo-inductive or osteo-conductivematerial or any combination of these. The first substance 208 may alsobe impregnated with bone marrow or BMP or any osteo-inductive orosteo-genic materials or any other such type of materials. The tape 202may be packed in the posterior end of the space 210 such that it abutsthe first substance 208. The tape 202 can be impregnated with biologicalglue or biological cement. Such a procedure can be adopted when intendedpurpose is disc fusion or regeneration.

FIG. 2B is a top view 200B of the embodiment shown in FIG. 2A. As shown,tape 202 is packed in space 210 such that it abuts a first substance208. FIG. 2C is a top view 200C of another embodiment wherein, after theempty space 210 is packed with the first substance 208 and the tape 202,the opening in the annulus 250 is closed by stapling a plate or apolyethylene or similar membrane 252 known in the art.

In another embodiment (not shown), the tape 202 can be used toreconstruct missing portion of the bone from trauma, degeneration, orsurgical excision. The procedure shall be same as followed for discfusion. The empty space caused by the missing bone can be treated likean empty disk space and packed using morselized bone preferablyauto-graft and thereafter tape 202 made of bio absorbable material andimpregnated with bone marrow can be packed.

FIGS. 3A-3B illustrate creation of an artificial disk using anembodiment of the tape described earlier. FIG. 3A illustrates aperspective view 300A of a tape 302 packed in an empty disc space 310.The tape 302 can include a tape body 304 and a support member 306. Theempty space 310 is present between two parts 312 and 314. In practice,parts 312 and 314 can be vertebrae of the spine and empty space 310 canbe a void left after discectomy that may need filling for artificialdisc formation. The anterior portion of the space 310 may be filled witha second substance 308. The second substance 308 may include anysuitable matter, such as, polyethylene balls 308. In practice, theanterior portion of the empty space 310 may be first filled withpolyethylene balls 308, and thereafter the posterior of empty space 310can be packed with tape 302. The tape 302 can be impregnated withbiological glue or biological cement. Such a procedure can be adoptedwhen intended purpose is creation of an artificial disc.

FIG. 3B is a top view 300B of another embodiment wherein, after theempty space 310 is packed with the second substance 308 and the tape302, an opening in the annulus 350 is closed stapling a plate or apolyethylene or similar membrane 352 known in the art.

FIG. 4 illustrates a top view 400 of disk 408 having an empty disk space403. When the intended purpose is regeneration of the disk, the diskremoval can be minimal to ensure that all the potentially healthy diskmaterial remains intact. The limited empty space in the disk 408 canthen be packed with tape 402 made of bio absorbable material,incorporating stem cells or other tissues capable of regenerating thedisk 408. Thereafter, the opening in the annulus 404 can be closed bystapling a plate or a polyethylene or similar membrane 406 known in theart.

FIG. 5 illustrates an exemplary method flow diagram 500 for disc fusionusing the tape. At step 502 of the process, the disk space can bethoroughly cleaned out. At step 504, partial thickness of the corticalend plates can be removed by scraping with a suitable device, such as, acurette. At step 506, a desired lordosis for that particular disc can becreated, using a specialized instrument. (An exemplary instrument forcreating the lordosis is described below with reference to FIGS. 8A and8B). At step 508, an anterior portion, for example, an anteriortwo-third of the disk space can be packed with a first substance, suchas, morselized bone, preferably autograft. At step 510, the remainderposterior portion, for example, the remaining one-third disk space canbe packed with a tape made of a bio compatible material and may beimpregnated with bone marrow, BMP, or other osteo-inductive andosteo-genic material. At step 512, on completion of the packing, asquare or rectangular piece of polyethylene or similar membrane or aplate, can be stapled to close the disk annulus that can facilitatecontainment of the tape mass inside the disk space. The membrane can beof same material as used for the body of the tape.

FIG. 6 illustrates an exemplary process flow diagram 600 for creating anartificial disc using the tape in accordance with an embodiment. Asshown, at step 602, the disk space can be thoroughly cleaned out. Atstep 604, a partial thickness of the cortical end plates can be removedby scraping with a suitable device, such as, a curette. At step 606,using a special instrument, a desired lordosis for that particular diskcan be created. At step 608, an anterior portion, for example, atwo-third of the disk space can be packed with a second substance, suchas, polyethylene or similar balls. At step 610, the remainder posteriorportion, for example, the remaining one-third disk space can be packedwith a tape made of a bio compatible material and impregnated withappropriate biological glue or polyethylene or similar material that canhelp to convert the packed tape into one single mass, trapped in thedisk space and behaving like an artificial disk. On completion ofpacking and at step 612, a square or rectangular piece of polyethyleneor similar membrane or a plate can be stapled to close the disk annulusin order to facilitate containment of the tape mass inside the diskspace. The membrane can be of same material as used for the tape.

FIG. 7 illustrates an exemplary process flow diagram 700 for discregeneration using the tape in accordance with an embodiment. When theintended purpose is regeneration of the disk, the disk removal to cleandisc space at step 702 can be minimal to ensure that all the potentiallyhealthy disk material remains intact. At step 704, the empty space inthe disk can then be packed with the tape. The tape can incorporate stemcells or other tissues capable of regenerating the disk. Thereafter, atstep 706 the opening in the annulus can be closed by stapling apolyethylene or similar membrane or a suitable plate.

According to an embodiment, the tape can be tightly packed in an emptydisk space manually or by using a specialized impacting instrument (notshown).

FIGS. 8A and 8B illustrate an exemplary instrument 800 for creating adesired lordosis. FIG. 8A illustrates a lordosis disk spreader 800. Thelordosis disk spreader 800 includes an elongated cylindrical body 810. Apair of upper and lower wedged-shaped members 830A, 830B are formed at afront end of body 810. A distal end of the body 810 includes a firsthandle 820. An elongate cylindrical column 840 is inserted within thebody. The column 840 terminates in a second handle 825. As illustratedin FIG. 8B, the lordosis disk spreader 800 can be actuated by pushingthe second handle 825 toward the first handle 820. This causes thecolumn 840 to be propelled within the body 810 such that a front end ofthe column 845 extends out between the wedge-shaped members 830A, 830Bthereby creating the desired lordosis.

Thus, the embodiments of the tape can be used during spinal surgeriesfor packing empty intervertebral space and empty space in vertebralbody/bone with an intention of fusing vertebrae, creating an artificialdisc, helping regeneration of the disc, or to reconstruct missingportion of disc or bone from trauma, degeneration, or surgicalexcisions.

Groupings of alternative elements or embodiments of the inventiondisclosed herein are not to be construed as limitations. Each groupmember can be referred to and claimed individually or in any combinationwith other members of the group or other elements found herein. One ormore members of a group can be included in, or deleted from, a group forreasons of convenience and/or patentability. When any such inclusion ordeletion occurs, the specification is herein deemed to contain the groupas modified thus fulfilling the written description of all Markushgroups used in the appended claims.

While the foregoing describes various embodiments of the invention,other and further embodiments of the invention may be devised withoutdeparting from the basic scope thereof. The scope of the invention isdetermined by the claims that follow. The invention is not limited tothe described embodiments, versions or examples, which are included toenable a person having ordinary skill in the art to make and use theinvention when combined with information and knowledge available to theperson having ordinary skill in the art.

The invention claimed is:
 1. A method for disc regeneration comprising:cleaning a disc space to create an empty space, wherein cleaning thedisc space further comprises the step of: removing a minimal amount ofdisc material such that healthy disc material remains intact; packingthe empty space in the disc with a disc or vertebral defect packingtape, the tape comprising: one tape body; and one or more supportmembers for holding the tape body together, wherein the one or moresupport members are: (A) contained within the tape body as an internalsupport member, wherein the tape body is wider than the internal supportmember; and/or (B) substantially enveloping an external surface of thetape body as an external support member, wherein the external supportmember comprises a fine mesh of biocompatible material, wherein the tapebody is configured as a packing material for packing an emptyintervertebral disc space, and wherein the tape body is selected from agroup consisting of a biologically absorbable material, stem cells,finely ground materials, or a combination thereof; and closing anopening in an annulus of the disc.
 2. The method according to claim 1,wherein the tape is impregnated with stem cells or other materialscapable of facilitating disk regeneration.
 3. The method according toclaim 1, wherein the internal and external support members comprise abiocompatible material and/or a biologically absorbable material.
 4. Themethod according to claim 1, wherein the internal support membercomprises a plurality of beaded elements.
 5. The method according toclaim 4, wherein the beaded elements comprise titanium beads.
 6. Themethod according to claim 5, wherein the beads are interconnected withtitanium fiber.